DepressionMSMNCT01220635
Middle School Matters Study
A study testing Positive Thoughts and Actions Program and Individual Support Program in people with Depression, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression
- What is being tested?
- Positive Thoughts and Actions Program and Individual Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 7th and 8th grade students at 4 participating middle schools
- Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%)
- No imminent plans to move or change to non-participating school
- At minimum 6th grade language skills
- Agree to participate in random assignment and research interviews
- One Parent/caregiver willing to complete research interviews
Who cannot join
- Student with past or current Major Depressive Disorder (MDD) or Probable MDD
- Students with parents who do not speak English or Spanish
- Students in concurrent treatment
- Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member
- Parent not willing to complete research interviews
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Depression Within Salient Adolescent Contexts
This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.
Read the detailed description
This study involve two parts: Part 1 entailed screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress. Students who score at the designated cutoff on a depression symptoms measure received a brief check-in to determine eligibility for the follow up randomized trial (Part 2). An "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, Individual Support Program (ISP) comparison group or a Skills Group Program. Research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures. Following completion of the intervention, all participants were followed for 12-months.
- Conditions
- Depression
- Being tested
- Positive Thoughts and Actions Program, Individual Support Program
- Keywords
- Depressive Symptoms, Depression prevention, Adolescents, School-Based Services, Health Behavior
- Medical subject headings
- Depression, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Thoughts and Actions ProgramBehavioural
Students in the skills group will attend a 12-session (50 minutes each), 12-week program with 4-6 other students. The skills group will take place at school during school hours. Parents in the skill group will be asked to participate in two parent group workshops to take place at their child's school or other participating middle school (2-hours each). In addition, the skill group leader will conduct two individual family meetings with the student and parent(50 minutes each).
Individual Support ProgramBehavioural
Students will be individually interviewed (60-90 minutes) at school to review areas of stress and support. The health professional conducting the interview will reinforce the student's strengths, and provide connections to sources of help from caring adults at home and at school. Parents will be called following the assessment to help the family locate appropriate resources if needed (e.g., tutoring resources, school counselor).
| Study group | Role | What they receive |
|---|---|---|
| Skill Group Program | Experimental | Positive Thoughts and Actions Program Receives: Behavioral: Positive Thoughts and Actions Program |
| Individual Support Program | Active comparator | Measure of Adolescent Potential for Suicide (MAPS) - modified Receives: Behavioral: Individual Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moods and Feelings Questionnaire (MFQ; child and parent version)
Depressive symptoms of the child are assessed on the MFQ. Youth completed the MFQ at all 4 timepoints, parent ratings of students symptoms were collected at baseline, post-intervention, and 12 month follow up.
Measured: up to 1 year
Secondary outcomes (5)
Parent-Child Communication (PCC; child and parent version)
Parent child communication were assessed using the child and parent version of the PCC. Children completed the PCC at all 4 timepoints, parent ratings were collected at baseline, post-intervention, and 12 month follow up.
Measured: up to 1 year
Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)
The adolescent version of the Teacher Rating Scale, Parent Rating Scale, and the Student Self-Report of Personality of the BASC-2 were used to assess school functioning and social functioning.
Measured: up to 1 year
Health Enhancing Behavior Index (HEBI)
Health behaviors (diet, exercise, and sleep) are self-reported by the youth on the HEBI.
Measured: up to 1 year
Service Use Interview (Service for Children and Adolescence Parent Interview-modified)
The service use interview was used to measure treatment history and services received during the course of the intervention and follow up.
Measured: up to 1 year
Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)
The depression module of the KSADS was used to assess DSM-IV symptoms of major depression and depressive disorder at the 12-month follow up.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Carolyn McCarty, Seattle Children's Hospital
- Investigators
- Carolyn A McCarty, Ph.D., Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220635
- Sponsor's protocol ID
- R34 MH083706
- Other IDs
- 5R34MH083076-03
- Acronym
- MSM
- Status last verified
- Feb 2014
- First submitted
- 5 Oct 2010
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Duong MT, Kelly BM, Haaland WL, Matsumiya B, Huey SJ Jr, McCarty CA. Mediators and Moderators of a School-Based Cognitive-Behavioral Depression Prevention Program. Cognit Ther Res. 2016 Oct;40(5):705-716. doi: 10.1007/s10608-016-9780-2. Epub 2016 Apr 28.
PubMed 27795599
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Depression Within Salient Adolescent Contexts
- ClinicalTrials.gov ID
- NCT01220635
- Acronym / sponsor ID
- MSM / R34 MH083706
- Conditions
- Depression
- Keywords
- Depressive Symptoms, Depression prevention, Adolescents, School-Based Services, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.
Detailed description
This study involve two parts: Part 1 entailed screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress. Students who score at the designated cutoff on a depression symptoms measure received a brief check-in to determine eligibility for the follow up randomized trial (Part 2). An "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, Individual Support Program (ISP) comparison group or a Skills Group Program. Research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures. Following completion of the intervention, all participants were followed for 12-months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skill Group Program | Experimental | Behavioral: Positive Thoughts and Actions ProgramPositive Thoughts and Actions Program |
| Individual Support Program | Active comparator | Behavioral: Individual Support ProgramMeasure of Adolescent Potential for Suicide (MAPS) - modified |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 7th and 8th grade students at 4 participating middle schools
- Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%)
- No imminent plans to move or change to non-participating school
- At minimum 6th grade language skills
- Agree to participate in random assignment and research interviews
Key exclusion criteria (5 listed)
- Student with past or current Major Depressive Disorder (MDD) or Probable MDD
- Students with parents who do not speak English or Spanish
- Students in concurrent treatment
- Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member
- Parent not willing to complete research interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Thoughts and Actions ProgramStudents in the skills group will attend a 12-session (50 minutes each), 12-week program with 4-6 other students. The skills group will take place at school during school hours. Parents in the skill group will be asked to participate in two parent group workshops to take place at their child's school or other participating middle school (2-hours each). In addition, the skill group leader will conduct two individual family meetings with the student and parent(50 minutes each). | Behavioural | Skill Group Program |
| Individual Support ProgramStudents will be individually interviewed (60-90 minutes) at school to review areas of stress and support. The health professional conducting the interview will reinforce the student's strengths, and provide connections to sources of help from caring adults at home and at school. Parents will be called following the assessment to help the family locate appropriate resources if needed (e.g., tutoring resources, school counselor). | Behavioural | Individual Support Program |
Primary outcome
Moods and Feelings Questionnaire (MFQ; child and parent version)
Time frame: up to 1 year
Depressive symptoms of the child are assessed on the MFQ. Youth completed the MFQ at all 4 timepoints, parent ratings of students symptoms were collected at baseline, post-intervention, and 12 month follow up.
5 secondary outcomes
Parent-Child Communication (PCC; child and parent version)
Time frame: up to 1 year
Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)
Time frame: up to 1 year
Health Enhancing Behavior Index (HEBI)
Time frame: up to 1 year
Service Use Interview (Service for Children and Adolescence Parent Interview-modified)
Time frame: up to 1 year
Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
- Derived from this study: PubMed 27795599Duong MT, Kelly BM, Haaland WL, Matsumiya B, Huey SJ Jr, McCarty CA. Mediators and Moderators of a School-Based Cognitive-Behavioral Depression Prevention Program. Cognit Ther Res. 2016 Oct;40(5):705-716. doi: 10.1007/s10608-016-9780-2. Epub 2016 Apr 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn A McCarty, Ph.D. principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Thoughts and Actions Program and Individual Support Program in people with Depression, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moods and Feelings Questionnaire (MFQ; child and parent version) (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.